Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW597599 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Vestipitant 15mg once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GW597599 | DRUG | GW597599 15mg tablet |
| Placebo | DRUG | Placebo to match GW597599 15mg tablet |
Inclusion Criteria: * Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42 * PSG variables collected during 2consecutive PSG screening nights falling as follows: ...
GW597599 is an investigational small molecule being studied for sleep disorders and postoperative nausea and vomiting. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
GW597599 is an NK-1 receptor antagonist, as indicated by its study as an NK-1 anti-emetic medication. It targets the neurokinin-1 receptor to address nausea and vomiting, and it is also being studied for sleep disorders.
GW597599 is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the drug's safety and efficacy.
GW597599 is in Phase 2 clinical development. It has completed Phase 2 trials for postoperative nausea and vomiting and sleep disorders, but it is not yet approved and remains under investigation.
GW597599 has been studied in two completed Phase 2 trials: NCT00600990, which enrolled 624 female patients for postoperative nausea and vomiting prevention, and NCT00992160, a 28-day tolerance study in 161 participants with sleep disorders. Both trials are completed.
Yes, GW597599 is also known as vestipitant. The clinical trial NCT00992160 is titled 'Vestipitant 28-day Tolerance Study,' confirming that GW597599 and vestipitant refer to the same investigational drug.